Validation & Qualification of Containment Systems Online Event

Event Details
Principal Process Validation Consultant
ValSource Inc.

This webinar provides a practical, regulatory-focused overview of the validation and qualification of containment systems used in pharmaceutical manufacturing. It explains how to demonstrate that containment equipment and associated systems operate reliably and in line with regulatory expectations across their full lifecycle, from user requirements and risk-based design through qualification, performance testing, and ongoing verification. The session addresses key testing activities, including leak, airflow, pressure differential, and filter integrity testing, as well as system monitoring and documentation practices that support effective contamination control and inspection readiness.

Key Takeaways

  • Lifecycle approach to containment validation and qualification, from URS and design qualification through IQ, OQ, and PQ, for isolators, RABS, and robotic systems
  • Risk-based system design to mitigate cross-contamination risks and protect operator safety, aligned with Contamination Control Strategy (CCS) principles
  • Implementation and operation of effective containment controls, including barrier systems, airflow management, filtration integrity, and pressure monitoring
  • Validation testing and supporting data to demonstrate containment performance under worst-case conditions, supported by practical case studies from pharmaceutical manufacturing
  • Regulatory expectations and documentation, including current EU GMP Annex 1 requirements for barrier systems and inspection-ready compliance
  • Current state of the art and emerging technological developments in containment and pharmaceutical robotics, based on operational experience shared by industry experts
  • Ongoing verification, performance monitoring, and trending to ensure sustained containment system performance during routine operation

    Who Should Attend

    Quality Assurance, Quality Systems, and GMP Compliance professionals
    Validation, Qualification, and Technical Services engineers
    Process Engineering, MS&T, and Technology Transfer teams
    Engineering, Facilities, Utilities, and System Design specialists
    Contamination Control, Microbiology, and Environmental Monitoring teams
    Manufacturing, Operations, and Production Management personnel
    EHS, Industrial Hygiene, and Occupational Safety professionals
    Regulatory Affairs, Audit, and Inspection Readiness teams
    Project Managers supporting facility upgrades or new containment installations
    Site Leadership and Senior Management responsible for GMP compliance and containment strategy

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  • Full online access
  • Post-event documentation
  • Certificate of attendance
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    Event Details